Active — Not RecruitingNot Applicable

A Feasibility Study Evaluating Surgery for Mesothelioma After Radiation Therapy Using Extensive Pleural Resection

Canada15 participantsStarted 2019-09-05

Plain-language summary

This study aims to find the maximum tolerated dose level for malignant pleural mesothelioma patients receiving background radiation + boost radiation, and surgery. Boost radiation is an experimental form of radiation that involves targeting non-uniform high doses of radiation to bulky pleural masses. We hypothesize the immunologic abscopal effect is an important component in controlling disease, and may be stimulated with highly hypofractionated doses. Doses will increase with every three patients who will be enrolled in the study until the background radiation reaches 1800 cGy or the maximum tolerated dose, whichever is lower.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Good pulmonary function precluding radiation therapy (FEV1\>1 L or \>40% predicted or DLCO \>45% predicted) * Any patient with a new histological diagnosis of malignant pleural mesothelioma (MPM). Sarcomatoid or biphasic histologies can be included but will be analyzed separately due to their poor prognosis. * Stage T1-3 N0-1 M0 according to the 8th edition of the tumor, node, and metastases (TNM) staging system based on conventional investigations and tests (Appendix 1). Note that the updated TNM staging system now categorizes ipsilateral mediastinal nodes as N1 disease. * Suitable for combined modality therapy * Informed consent. Exclusion Criteria: * Age \< 18 years. * Contralateral mediastinal nodal disease (N2) * Distant metastatic disease (M1). * Poor performance status ECOG 3-4. * Poor pulmonary function precluding radiation therapy (FEV1\<1 L or \<40% predicted or diffusion lung capacity for carbon monoxide (DLCO) \<45% predicted) * Failure to provide informed consent. * Previous thoracic irradiation. * Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment. * Previous chemotherapy for this or concurrent malignancy. * Previous or concomitant malignancies except for patients with non-melanoma skin cancer, contralateral non-invasive breast cancer, prost…

What they're measuring

Maximum Tolerated Dose for Background Radiation

Timeframe: Up to five years

Trial details

NCT IDNCT04028570

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04